Validated Reverse Phase High Performance Liquid Chromatography Technique for Quality Analysis of Rosuvastatin Calcium Molecule in Tablet Dosage Form

IntroductionA simple, reliable, precise reverse phase high performance liquid chromatography (RP-HPLC) method has been developed and validated for the estimation of rosuvastatin calcium in tablet dosage form. MethodsRP-HPLC separation was achieved on an C18, 5µm particle size (150mm x 4.6mm ID) column using a mobile phase of KH2PO4 and methanol (70:30) at a flow rate of 0.75ml/min at temperature of 400C, run time 10 min detected at 242 nm using UV detector. The method was validated for system suitability, linearity, accuracy, precision and robustness. ResultsThe method was found to be linear in the drug concentration range of 38 –72 µg/ml with correlation coefficient of 0.9996. The precision relative standard deviation was 1.07 which shows the method is precise. The accuracy minimum recovery value was 98.5 % and maximum recovery value was 101.97 %. ConclusionsThe developed method is basic, fast, precise and reproducible and thus can be used for the routine quality analysis of rosuvastatin calcium.